Device Classification Name |
Wrap, Sterilization
|
510(k) Number |
K141693 |
Device Name |
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator |
Applicant |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Applicant Contact |
SUN CHOI |
Correspondent |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
SUN CHOI |
Regulation Number | 880.6850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/24/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|